J U LY 2 0 1 5 O U T P A T I E N TS U R G E R Y. N E T 9
saline performed poorly in this
group, with patients experiencing
moderate pain throughout the study
period.
• A study pitting Exparel against
bupivacaine HCl for hemorrhoidec-
tomy resulted in a tiny edge for
straight bupivacaine; it performed
better in 2 out of 60 measurement
points. In the sponsor's own study,
the old $2.80 standby beat the $285
one.
From his comments, it appears that Dr. Simone was far less than impressed. He
points out that "the duration of Exparel's analgesic effect appears to be no more
than 24 hours and not longer than that of bupivacaine hydrochloride. The last study
failed to show a difference between [Exparel] and [bupivacaine]."
On to market
On the strength of its performance against saline, however, Exparel won FDA
approval late in 2011. The approval simply stated that the drug was for "single-
dose administration into the surgical site to produce postsurgical anesthesia."
The FDA's Dr. Simone may have had his opinions, but Pacira apparently dis-
agreed with him, and wasted no time pressing the case for what it thought its
new drug could do.
In what would become a familiar refrain in Pacira promotion and sales pre-
sentations, a Pacira press release trumpeted the assessment of Harold
Minkowitz, MD, a Texas anesthesiologist and Pacira consultant. "Typically, the
first 48 to 72 hours after surgery are the most difficult from a pain-management
perspective, so a product like Exparel, which can provide pain relief with
z PRECISE ADMINISTRATION Exparel's
extended-release feature means you must
infiltrate it in a very specific manner.
Peter
G.
Whang,
MD,
FACS
